Product Alert

FDA Expands Black Box Warning on Iron Deficiency Drug

WASHINGTON -- The FDA has strengthened the black box warning for injectable iron dextran (Dexferrum), cautioning physicians to try a test dose first, due to a risk of anaphalactic reactions and even death.

The modified warning cautions that fatal reactions have occurred even after the test dose was tolerated. The drug is indicated for end stage renal disease patients with an iron deficiency who are not amenable to oral iron therapy.

The new FDA warning recommends that resuscitation equipment be available, with personnel trained to detect and treat anaphylactic reactions, while administering iron dextran injections.

Patients with a history of drug allergy are most susceptible to to these serious adverse affects. They are also more likely to occur with large doses of the drug, and may be delayed.

Cole Petrochko started his journalism career at MedPage Today in 2009, after graduating from New York University with B.A.s in Journalism and Psychology. When not writing for MedPage Today, he blogs about nerd culture, designs websites, and buys and sells collectible card game cards. He is based out of MedPage Today's Little Falls, N.J. Headquarters.

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